Looking over 2011: #FDA has high number of #medicine approvals

In Clinical Trials by Simon Crompton-ReidLeave a Comment

FDA, US Food and Drug Administration, orphan drugs, rare diseases, lupus, World Orphan Drug Congress, regulation, legislation The US Food and Drug Administration presented 35 approvals in the last year. The number is high, and Catalyst highlights the fact that 10 were orphan drugs for rare diseases.

The first new therapy for lupus, researched for 50 years, is on the list, and 7 are medicine advances for cancer treatments.

Read more information here.

What are the perspectives for this year? FDA will be at Terrapinn's World Orphan Drug Congress USA 2012 analyzing the following topics:

- Importance of natural history studies in rare diseases

-  The approach to improve pediatric regulatory impact

- Pediatric regulation for a global market

- Ethical aspects of clinical trial design

Understand the latest news about legislation, hear how governments in the US, Europe, Cana, Japan, Brazil and Taiwan are working together to harmonize regulations and incentive orphan and pediatric drug development.

Watch Dr. Timothy Cote, Director at the Office of Orphan Product Development for FDA speaking about strategies to address unmet patient needs at the conference last year.

The agenda and more information about the 2012 edition available online.

 

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